Several Stem Cell Stocks Trade Higher After Aastrom's Clinical Hold is Lifted Print E-mail
By M.E.Garza   
Friday, 19 June 2009 03:44

Aastrom Biosciences Inc (Nasdaq:ASTM) said U.S. health regulators removed the clinical hold from the company's mid-stage trial of a treatment for congestive heart failure, sending its shares up as high as 39 percent on Thursday.

The company said it would resume patient enrollment at all five initiated clinical sites. In May, the U.S. Food and Drug Administration (FDA) decided to put the trial on hold following a patient's death, leading Aastrom to temporarily suspend enrollment and patient treatment in the trial, called IMPACT-DCM.

The trial is evaluating the use of Cardiac Repair Cells (CRCs), a mixture of stem and progenitor cells derived from a patient's own bone marrow, for the treatment of dilated cardiomyopathy (DCM), a severe form of chronic heart failure.

On June 17, 2009, the FDA informed Aastrom that it had completed its investigation into the death of a patient following treatment with the Company's CRCs and that the clinical hold had been lifted; therefore, the IMPACT-DCM clinical trial could resume. Based on autopsy results and medical records, the FDA, the clinical site's principal investigator and an independent Data Safety Monitoring Board (DSMB) have attributed the patient death to progression of the disease and

determined it was unrelated to the CRC treatment.

"Patient safety is top priority for Aastrom. We are saddened by the loss of one of our patients. At the same time, we are grateful that this investigation was conducted in an efficient manner and

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that the FDA was able to provide prompt review and
remove the clinical hold so quickly. This comprehensive review, along with the FDA's permission to carry on the trial without modifications, underscores the safety of the trial design and that our CRC product played no role in the patient's death," stated George W. Dunbar, President and Chief Executive Officer at Aastrom. "We do not expect that this short delay will interfere with our goal of completing patient enrollment in this trial by the end of calendar year 2009. We are eager to resume patient enrollment and treatment in the IMPACT-DCM trial and to continue evaluating the clinical data we gather from these patients."

"As unfortunate as this death is, it illustrates the severity of this disease and the need for a new therapeutic option for these patients who currently have limited alternatives other than a heart transplant or the implantation of a mechanical assist device," said Dr. Amit Patel, Associate Professor of Surgery at the University of Utah School of Medicine and the National Principal Investigator of the IMPACT-DCM clinical trial. "At this time it is important to recall that the patients recruited into the IMPACT-DCM trial are in end-stage heart failure with ejection fractions below 30%. In contrast, many other comparable cardiac stem cell trials require an ejection fraction above this threshold. Therefore, we are only treating the most critically ill patients. The findings from the IMPACT-DCM trial could eventually have a significant impact on how congestive heart failure is treated in the future."

The news sent other Stem Cell companies higher as well on Thursday.

Shares for Neuralstem, Inc.(AMEX:CUR) were up $1.09 +0.02 (1.87%). This is a company that will soon start tests for Lou Gehrig’s disease. The tiny, Rockville, Maryland based biotech is behind the human stem cells that have helped paralyzed rats walk again.

‘‘Our plan does assume that we can help paralyzed people," said Richard Garr, co-founder, president and CEO.

Neuralstem uses patent-protected technology that allows them to produce neural stem cells with the ability to control the differentiation of the cells into physiologically relevant human neurons and glia. Once approved by the FDA, these cells could be transplanted into humans as treatments for currently incurable diseases. The company expects to file a second IND for Traumatic Spinal Cord Injury in the first half of 2008 and begin Phase 1 trials for Traumatic
Spinal Cord Injury in the second half of 2008.  In late 2008, CUR expects to file a third IND for Lou Gehrig's disease (ALS).

Geron Corporation (NASDAQ:GERN) traded up to $6.67 +0.22 (3.41%) . This is another stem cell company that hopes to make parapalegics walk again. Geron reported in 2005 that a study it financed showed the treatment could help paralyzed rats walk and since genetically, those creatures share 99.94% of the same DNA, investors hope the treatment will also work in humans. In their study, embryonic cells were used and since those types of cells can turn into any type of tissue in the body, the cells were coaxed into developing into oligodendrocytes. Those are cells that help nerve fibers replace myelin, a fatty substance that provides insulation, which is important for motor function. When a spine is damaged, myelin often is stripped off. That can disrupt the body’s ability to transmit sensory signals – similar to the way an electrical cord shorts out when its insulation is peeled away – resulting in paralysis.

Pluristem Therapeutics Inc.(NASDAQ:PSTI) shares traded up very modestly to $1.30 +0.03 (2.36%). They exploded two days earlier- after the German competent authority in the European Union, has approved the Company’s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

StemCells, Inc.(NASDAQ:STEM) was another stem cell company that traded in positive territory to $1.65 +0.03 (1.85%). President and Chief Executive Officer Martin McGlynn present a very positive update on the company at the Jefferies & Company Third Annual Healthcare Conference in New York City yesterday. Investors are excited and feel that shares may see a bump on Friday from some of the good financial news he delivered. We'll see if they are correct.

Disclosure: No positions




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